An inspection was carried out by the Austrian national regulatory authority, AGES
Vetter, a global CDMO, has received manufacturing authorisation for its site in Rankweil, Austria. As a result of an inspection from the national regulatory authority, the Austrian Agency for Health and Food Safety (AGES), the site can now support clinical development projects of international pharmaceutical and biotech companies. The service provider purchased the approximately 10,000 sqm manufacturing facility in 2020.
The facility represents a European counterpart to the company’s existing clinical manufacturing site near Chicago, responding to the growing global demand for fill & finish services. The Austrian facility increases the company's capacity in the important field of process development as well as clinical manufacturing of Phase I and II injectables for customers.
"We are consistently investing in the expansion of our development and filling capacities," said Dr Claus Feussner, Senior VP, Vetter Development Service. "Our ambition is to support our customers in the best possible way on their journey to develop promising new therapies for patients. The site's approval is an important step in our strategic company development."
Since acquiring the site in the middle of 2020, the company has modified and equipped all laboratory, technical and production areas to its internal standards. In addition, the company reportedly optimised numerous systems and processes.
"For pharmaceutical companies and their service providers, it has to be the ultimate goal to fully comply with the regulations of Good Manufacturing Practices (GMP). This ensures the quality of the manufactured medicinal products and therefore also the patient safety," said Wolfgang Weikmann, Vetter’s Senior VP of Quality Assurance and Quality Control. "The comprehensive inspection conducted by the AGES revealed that the systems and processes implemented at the Rankweil site are fully capable to fulfill the high quality requirements.”
The successful inspection enables the facility to officially start operations and begin customer projects in the clinical development phase.